Novel Guidance Device for Image Fusion and Needle Guidance in Lung, Liver or Kidney Biopsy

February 7, 2023 updated by: Clear Guide Medical
This study investigates whether a new image fusion technology can reduce patient radiation dose from CTs and/or procedure time during biopsies of lung, liver or kidney.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This study proposes the use of a new fusion technology, Scenergy (Clear Guide Medical; FDA 510(k) K171677), which fuses CT images to real-time US images to minimize the drawbacks of each modality while enhancing their benefits. Such benefits include, the reduction of radiation dose to the patient with the fusion of initial CT imaging overlaying the live US images. The fused imaging software allows the operator to watch the needle tip advance towards the lesion on both live US and overlaid CT imaging. In such a setting, the operator would only need to perform an initial CT scan, advance the needle into position using fused US/CT images, and a final CT scan to ensure needle tip location. This eliminates interval CT scans that are usually required after each incremental needle position adjustment, and thus, reduces radiation dose to the patient and wasted procedural time during the incremental CT scans.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all patients between the ages of 18 and 80 years old at time of procedure who are pre-scheduled for a lung, kidney, or liver biopsy.

Exclusion Criteria:

  • any patient who was under the age of 18 or over the age of 80 at time of the procedure or who does not wish to volunteer for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: CT-only guided biopsy
The current standard of care for biopsy at Temple University Hospital.
EXPERIMENTAL: SCENERGY-guided Biopsy
The use of the SCENERGY to fuse CT and Ultrasound for biopsy
Device: SCENERGY-guided Biopsy
Use of SCENERGY during a lung, liver or kidney biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation Dose during Procedure
Time Frame: 1 hour
The number of CTs or Fluoroscopy shots during the biopsy
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Reach Target of Biopsy
Time Frame: 1 hour
The amount of time in seconds that the physician takes to reach the target of biopsy
1 hour
Experience Level
Time Frame: 1 hour
Number of years physician has practiced in Interventional Radiology
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clear Guide Medical

Collaborators

National Institutes of Health (NIH)
Temple University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 31, 2019

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

December 31, 2020

Study Registration Dates

First Submitted

July 29, 2019

First Submitted That Met QC Criteria

July 30, 2019

First Posted (ACTUAL)

July 31, 2019

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TUH SCENERGY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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